Evaluating FDA Practices for Recruiting and Retaining Human Drug Review Staff

Efficient and effective reviews of drug marketing applications are vital to the Food and Drug Administration’s mission to improve and protect public health in the United States. FDA strives to hire and retain skilled technical and scientific experts for their human drug review program. As the fields of medicine and drug development continue to grow more complex, requiring greater levels and types of specialized expertise—and industry and other entities also seek to employ staff with similar talents, hiring and retaining staff is challenging. In this context, FDA asked ERG to assess its human resource and human capital operations for human drug review staff, with a focus on changes that have improved FDA’s hiring and retention outcomes and the challenges that remain

ERG designed and implemented a large-scale comprehensive evaluation approach to learn about FDA’s practices for recruitment, hiring, pre-employment onboarding, and retention of human drug review staff—and associated successes and challenges. We reviewed large volumes of current and historical data from FDA, conducted several large-scale surveys, interviewed individuals and groups of FDA staff, and examined practices and outcomes of other federal agencies and industry for comparison and lessons learned. ERG analyzed all results to produce a public report describing our methodology, detailed results, answers to some core assessment questions, and findings and recommendations. We presented this information at a national public meeting hosted by FDA.